Results of HARMONY study of Botox Cosmetic (onabotulinumtoxinA) in glabellar lines and "crow's feet" lines- Allergan

Allergan presented the results of its HARMONY study, which assessed the overall impact and psychological benefits of multimodal injectable and topical treatment, in particular, Botox Cosmetic (onabotulinumtoxinA) for facial aesthetics. The study included 100 subjects (96 female) treated with onabotulinumtoxinA for moderate to severe glabellar lines (n=95) and crow's feet lines (n=96); hyaluronic acid dermal fillers (n=100) for the correction of age-related mid-face volume deficit and/or moderate to severe facial wrinkles and folds; and received bimatoprost ophthalmic solution 0.03% for eyelash hypotrichosis (n=100). Patients were administered the validated FACE-Q "Satisfaction with Face Overall" patient-reported outcome scale prior to treatment and at month four, which asked patients about their attitudes to their facial appearance. Additional FACE-Q modules assessed changes in social confidence, psychological wellbeing and how old patients felt they looked, both before and after treatment.

After receiving comprehensive pan-facial treatment, on average subjects reported being either very satisfied or somewhat satisfied with their facial appearance. Secondary FACE-Q endpoints of age appraisal, social confidence and psychological wellbeing scores showed highly positive benefits of treatment. Additionally, subjects reported looking an average of 4.3 years younger at the month 4 time point. Common treatment site reactions to fillers included bruising, tenderness, swelling and lumps. One treatment-related adverse event was reported with onabotulinumtoxinA (eyelid ptosis), and 5 were reported in 4 subjects with bimatoprost ophthalmic solution 0.03% (1 subject discontinued due to the adverse event). All observed adverse events were reported and were consistent with those reported in previous clinical studies. No serious adverse events were reported. Data were presented at the 2015 American Society of Dermatologic Surgery Meeting.